Methods and kits for quantifying the removal of mock virus particles from a purified solution

Abstract

The present invention relates to a method of quantifying the amount of Mock Virus Particles (MVP) removed from a solution as a result of processing that solution through a purification technique. This method involves the steps of adding MVP to a solution, processing the solution through a purification technique, quantifying the amount of MVP removed from the solution. The present invention also relates to a kit that can be used in conjunction with the method. This kit will comprise at least one stock solution of MVP and at least one quantification solution.

The invention claimed is: 
     
       1. A kit comprising:
 a stock solution comprising a modified Mouse Minute Virus (MMV) Mock Viral Particle (MVP), wherein the MMV MVP is a non-infectious, non-replicating assembled unit comprising a MMV VP2 viral capsid protein comprising an amino acid sequence having at least 99% identity to SEQ ID NO: 6, wherein said stock solution comprises at least 1×10 10  MMV MVP/ml of said MMV MVP and wherein non-MMV MVP proteins are less than 25% of all proteins in the stock solution. 
 
     
     
       2. The kit of  claim 1 , wherein said viral capsid protein is produced in a bacterium, yeast, plant, insect cell, animal or human cell. 
     
     
       3. The kit of  claim 1 , wherein non-MMV MVP proteins are less than 5% of all proteins in the stock solution. 
     
     
       4. The kit of  claim 1 , wherein the MMV MVP does not comprise a MMV VP1 viral capsid protein. 
     
     
       5. The kit of  claim 1 , wherein the MMV VP2 viral capsid protein is encoded by a nucleic acid comprising SEQ ID NO: 5. 
     
     
       6. The kit of  claim 1 , wherein the MMV VP2 capsid protein comprises SEQ ID NO: 6. 
     
     
       7. The kit of  claim 1 , wherein the kit further comprises an antibody that specifically binds to the MMV VP2 capsid protein comprising an amino acid sequence having at least 99% identity to SEQ ID NO: 6. 
     
     
       8. The kit of  claim 6 , wherein the kit further comprises an antibody that specifically binds to SEQ ID NO: 6.